Label: PROTECTIF UNTINTED- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4263-1, 62742-4263-2, 62742-4263-3, 62742-4263-4
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 17, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: Adults and Children over 6 months of age: Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging - to decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses
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OTHER SAFETY INFORMATION
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging - to decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses
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INACTIVE INGREDIENT
Inactive ingredients: Water (Aqua), Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31, Glycerin, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Dipropylene Glycol, Sodium Citrate, Tocopherol, Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone / Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-1011 Dimethicone, Hexyl Laurate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cetearyl Olivate, Sorbitan Olivate, Benzoic Acid, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Pentylene Glycol, Sodium Hyaluronate, Cyclohexasiloxane, PEG-8, Ascorbyl Palmitate, Ascorbic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Ferrocyanide Deca hydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetra peptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTECTIF UNTINTED
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.6 g in 100 g Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) HYDROXYTYROSOL (UNII: QEU0NE4O90) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) ASCORBIC ACID (UNII: PQ6CK8PD0R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ARABICA COFFEE BEAN (UNII: 3SW678MX72) SODIUM FERROCYANIDE DECAHYDRATE (UNII: CG0CLR485X) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SODIUM BENZOATE (UNII: OJ245FE5EU) ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CYCLOMETHICONE 4 (UNII: CZ227117JE) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) DIPROPYLENE GLYCOL (UNII: E107L85C40) CYCLOTETRAPEPTIDE-24 AMINOCYCLOHEXANE CARBOXYLATE (UNII: NR327745KQ) POLYSORBATE 20 (UNII: 7T1F30V5YH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) WINE GRAPE (UNII: 3GOV20705G) CETEARYL OLIVATE (UNII: 58B69Q84JO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) APPLE (UNII: B423VGH5S9) POLYSILICONE-15 (UNII: F8DRP5BB29) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SORBITAN OLIVATE (UNII: MDL271E3GR) ASCORBYL PALMITATE (UNII: QN83US2B0N) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9) GREEN TEA LEAF (UNII: W2ZU1RY8B0) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZOIC ACID (UNII: 8SKN0B0MIM) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PENTYLENE GLYCOL (UNII: 50C1307PZG) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLHEXYL PALMITATE (UNII: 2865993309) CYCLOMETHICONE 6 (UNII: XHK3U310BA) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ECTOINE (UNII: 7GXZ3858RY) ISOMALT (UNII: S870P55O2W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4263-2 1 in 1 CARTON 05/17/2024 1 NDC:62742-4263-1 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:62742-4263-4 1 in 1 CARTON 05/17/2024 2 NDC:62742-4263-3 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/17/2024 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4263)
